Label: 3CE TINTED MOISTURE CUSHION CC 002- titanium dioxide, octinoxate, octisalate powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 17, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: Titanium Dioxide 8.7%, Ethylhexyl Methoxycinnamate 6.7%, Ethylhexyl Salicylate 4.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Dimethicone, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, PEG-8 Dimethicone, Glycerin, Niacinamide, Pentylene Glycol, Trimethylsiloxysilicate, Iron Oxides (CI 77492), Methyl Methacrylate Crosspolymer, Neopentyl Glycol Diheptanoate, Dimethicone/Vinyl DimethiconeCrosspolymer, Diphenylsiloxy Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, PEG-8, Magnesium Sulfate, DisteardimoniumHectorite, Vinyl Dimethicone/MethiconeSilsesquioxaneCrosspolymer, SorbitanIsostearate, Phenoxyethanol, Mica (CI 77019), Stearic Acid, Alumina, Fragrance(Parfum), Iron Oxides (CI 77491), DimethiconeCrosspolymer, Triethoxycaprylylsilane, Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Hydrogenated Castor Oil Isostearate, Hydrolyzed Hyaluronic Acid, AnastaticaHierochuntica Extract, Alcohol, GentianaLutea Root Extract, AchilleaMillefolium Extract, Artemisia Absinthium Extract, Arnica Montana Flower Extract, Lactobacillus Ferment, Potassium Sorbate

  • PURPOSE

    Purpose: Sunscreen

  • CAUTION

    CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

  • DESCRIPTION

    INSTRUCTIONS: Layering Cushion CC covers face moisture as if it has done treatment. 3CE Tinted Moisture Cushion CC creates a moisture layer with a hydrating complex for dewy radiance.

    Directions: Take a small amount with the Ruby Cell Puff and spread evenly over face. Please make sure to close the lid after use.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    3CE TINTED MOISTURE CUSHION CC 002 
    titanium dioxide, octinoxate, octisalate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.04 g  in 12 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.80 g  in 12 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.48 g  in 12 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60764-130-022 in 1 CARTON08/10/2016
    1NDC:60764-130-0112 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/10/2016
    Labeler - Nanda Co., Ltd (557816075)
    Registrant - Nanda Co., Ltd (557816075)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanda Co., Ltd557816075repack(60764-130)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(60764-130)